This invention relates to an incontinence pessary having a shape more closely resembling the anatomic conformation of the vaginal vault. More specifically, the invention provides a design that confers stabilization in all three of the vaginal axes, the longitudinal axis, the antero-posterior axis, and the lateral axis, as well as, stabilization against rotation around these axes. In addition, the invention more specifically provides for an expanding flexible segment and/or electrode surface for engaging the periurethral tissue of the antero-superior vaginal vault.
Pelvic floor relaxation in women, as a natural result of childbirth, age and anatomic predisposition, often results in prolapse of one or more of the various organs within the pelvis, such as the uterus, urinary bladder, rectum and intestines. In particular, relaxation of the support to the urinary bladder and the urethra often results in urinary incontinence. Typically, this urinary incontinence is a form known as stress incontinence that results in leakage of urine at times of physical stress that suddenly increase the intraabdominal pressure, such as coughing, laughing, sneezing, or physical exercise.
Stress incontinence is not only a medical problem for the woman, but also creates social difficulty, as well. Inappropriate urine leakage may result in perineal skin maceration and skin breakdown, which can be further complicated by bacterial and fungal infection. In addition, the woman""s clothing becomes soiled and emanates characteristic urine malodor unless steps are taken to absorb the urine in devices such as pads or incontinence diapers.
A common solution to the problem of pelvic relaxation is the use of a pessary inserted within the vaginal vault. A number of different types of pessaries are available, ranging from cubes, doughnuts, rings, and discs, to blocks of material, each completely, or at least partially inserted within the vaginal vault. Pessaries having inflatable portions are also contemplated. In all cases, the pessary acts as a vaginal space-occupying device intended to support the organs and tissues of the pelvis when the woman""s own anatomic suspension has failed. Consequently, a pessary is subjected to prolong use and must maintain its positioning and support continuously while not interfering with normal activities of daily living. Additionally, there have been several pessaries designed for the treatment of urinary stress incontinence. These have not achieved their desired effect because they are not stable in all axes of vaginal orientation. Lack of stability in all axes allows for off axis forces to be applied to these pessaries, which causes misdirection of the force to the periurethral tissue and urethra relied on for continence by these devices.
However, the type and extent of pelvic relaxation and subsequent prolapse of any one or more organs and the degree of urinary incontinence encountered is highly variable from one woman to the next. Unfortunately, current pessary styles may provide relief for a particular aspect of the problem, but do not provide for adequate problem solving for all the difficulties encountered. As an example, a pessary may be well adapted for support of a prolapsing rectum, but is inefficient at providing simultaneous urethral support for control of stress incontinence. The rectum, uterus, and urinary bladder are midline anatomic structures that generally prolapse in the midline, or sagittal plane. The prolapsing organ places antero-posterior, longitudinal, lateral and/or rotational displacement forces on any pessary placed within the vaginal vault. When not stabilized against all of these forces, a pessary becomes displaced. This displacement of the pessary defeats the pessary""s function in controlling urinary incontinence by failing to support the urethra.
What is needed is an incontinence pessary that is anatomic in its orientation to various pelvic structures, providing continuous support of these organs. Such a pessary will also provide continuous control of urinary incontinence, provide for proper release of vaginal secretions, and not interfere with normal daily activities.
The present invention contemplates an incontinence pessary device for use within a vaginal vault of a woman that comprises a resilient main support body, at least two resilient lateral support bodies, and a suburethral support body. The main support body is generally a disc or torus shape of resilient material, the disc having a primary plane of orientation. The disc or torus shape provides for a differential response to compressive forces, particularly to forces applied to the disc or torus along the primary plane of the disc or torus.
As contemplated by the present invention, the main support body, when inserted in the vagina will be oriented with the plane of the disc or torus oriented to the sagittal plane of the woman""s pelvis. Thus, the main support body is in a position to counter the effects of any prolapsing organ, such as the urinary bladder, uterus or rectum into the vaginal vault. The prolapse movement of any of these organs will exert a compressive force on the main support body that is in the primary plane of the main support body. The orientation of such compressive forces may be any of the sagittal plane axes of orientation: antero-posterior, cephalo-caudal, and longitudinal, i.e., along the long axis of the vaginal vault. These forces are readily countered by the resiliency of the material used in the main support body.
A tendency for some pessaries, after placement in the vaginal vault, is to shift laterally or rotate out of position when encountering the forces applied to it along the sagittal plane. The present invention uses at least two resilient lateral support bodies to effectively counter this effort. The present invention contemplates that the lateral support bodies will be provided as opposing pairs, but the number of pairs used is not limited. The Description and Figures provided herein disclose the use of two lateral support bodies, although, any number of pairs may be used depending upon the degree of stabilization sought.
The lateral support bodies project at an angle from a position on the main support body toward generally opposite sides of the main support body. Each lateral support body generally sweeps backward and outward from the primary plane of the main support body. Each pair of lateral support bodies forms a secondary plane generally perpendicular to the primary plane. Thus, when the pessary of the present invention is placed within the vaginal vault, the lateral support bodies project posteriorly within the vaginal vault, and laterally from the sagittal plane of the pelvis. The ends of the lateral support bodies will abut the posterio-lateral vaginal wall with the rectum between the lateral supports.
The lateral support bodies also demonstrate a differential response to the compressive forces, the lateral support bodies being stiffer along their length than across their width. Forces that would tend to push the pessary laterally will be generally exerted along the secondary plane of each pair of lateral support bodies used. The lateral support bodies stabilize the pessary of the present invention by countering any tendency for the pessary to want to move laterally out of the way of a any prolapsing organ.
Additionally, the lateral support bodies stabilize the pessary in the anterop osterior axis keeping the suburethral support body intimately adjacent the mucosa of the periurethral tissues. The lateral support bodies are stiffer along the secondary plane in this antero-posterior axis and contribute directly to the pressure applied by the suburethral support body to the woman""s urethra to control incontinence. Note that either lateral forces or antero-posterior forces exerted on the lateral support bodies are designed to meet the lateral support bodies at oblique angles, limiting the mechanical advantage that might be encountered if met end on. This will ensure that there will always be some give in the lateral support bodies t o avoid inadvertent excessive forces that may be encountered, such as during a cough. Lastly, the lateral support bodies stabilize the present invention against rotational forces, especially limiting rotation around the lateral and longitudinal axes.
The suburethral support body is an elongate structure having its longitudinal axis laying within the primary plane of the main support body. The suburethral support body projects from a position on the main support body that is generally, but not necessarily, opposite the position from which the lateral support bodies arise. The longitudinal axis lays at an angle to the secondary plane of the lateral support bodies. Ideally this angle is an obtuse angle as measured going counter clockwise from the lateral support body position on the main support body. The angulation of the longitudinal axis of the suburethral support body in relation to the secondary plane of the lateral support bodies further stabilizes the device of the present invention against rotational forces, particularly stabilizing against rotation about the longitudinal and antero-posterior axes.
The present invention anticipates the use of a contact surface area oriented along the suburethral support body for directly abutting the mucosa of the periurethral tissues. This direct abutment provides the pressure to a substantial length of the urethra needed to achieve the continence control. The elongated nature of this abutment surface provides for a significant amount of surface area from which to deliver the pressure to the urethra. Spreading the pressure over a large area markedly decreases the likelihood of point pressure occurring and subsequent pain and tissue necrosis.
The urethra in the female lays along the sagittal plane and within the periurethral tissues in the superior wall, or roof of the distal portion of the vaginal vault. The course of the urethra is evident by a raised ridge in the surface of the mucosa of the vagina. The contact surface area of the suburethral support body may be improved by the addition of lateral prominences running substantially the length of the suburethral support body. These prominences are lateral to either side of the contact surface area and create a hollow, or recess, with the suburethral support area therebetween for the urethra to lay in. Thus, with the lateral prominences, the contact surface area will more closely approximate the geometry of the periurethral tissues and urethra, improving the overall contact and dispersion of continence efforts. These lateral prominences also contribute to stabilization of the present invention, particularly stabilization against rotation around the longitudinal axis.
The present invention further anticipates the use of an expansion membrane controllable by the woman. This may take the form of an inflatable chamber having a distendable membrane along the area of the contact surface. After placement of the pessary, the woman may apply increased continence effort by inflating this chamber with a suitable fluid medium. The woman may adjust the amount of inflation and, consequently, the amount of continence effort applied by the pessary to achieve the desired effect.
The present invention also contemplates the use of electrical stimulation applied directly to the periurethral tissues and urethra by electrodes carried on the contact surface. The electrical stimulation is used to create increased tone within the musculature of the periurethral tissue and the urethra directly. This increase muscular tone provides added continence control. Electrical stimulation capability also may be combined with the inflatable chamber and distendable membrane to further increase the range of continence control capability. In addition, having the various modalities contained within one pessary provides for the woman to alternate between the modalities.
The above and other objects and advantages of the present invention become more readily apparent when reference is made to the following detailed description taken in conjunction with the accompanying drawings. The following descriptions are in no way intended to limit the scope of the present invention.